Promoting Intensive Transitions for Children and Youth With Medical Complexity From Pediatric to Adult Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Transfer Completion
研究概览
简要总结
Medical advances have allowed many more children and youth with medical complexity (CMC) to survive well into adulthood. However, this has not been matched with increases in knowledge of complex conditions or the availability of supports as they transition into the adult care system. The goal of this randomized control trial is to compare intensive transition support from a transition team, led by an advance practice nurse, during transition to adult care for 2 years, with usual care in CMC. Participants assigned to the intervention group will be offered support in care planning, receiving funding, and connecting with a primary care provider and adult subspecialists.
The main questions it aims to answer are:
- Does intensive transition support improve the patient's continuity of care over 2 years compared with usual care?
- Will there be differences between intervention and control groups with respect to other outcomes related to the youth/family's satisfaction with care, care coordination, self-care, health service utilization, cost-effectiveness, and quality of life?
- What are the experiences of youth, parents, the transition team, and other clinicians involved in the intensive transition support process?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 210 Months 至 213 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 17 years 6 months- 17 years 9 months old (inclusive) who meet Ontario's CMC definition:
- •technology dependence and/or users of high-intensity care,
- •fragility (severe and/or life-threatening condition,
- •chronicity (expected to last at least 6 months),
- •complexity (involvement of ≥5 healthcare practitioners/teams and healthcare services in ≥ 3 locations such as home, school, hospital, etc.).
排除标准
- •are expected to die within 2 years of recruitment (e.g., those receiving active end-of-life care)
- •do not have a stable primary caregiver (e.g., those who reside in residential or long-term care facilities, and those in foster care as the intervention is focused on a patient-caregiver dyad)
研究组 & 干预措施
Intervention
干预措施: Intensive Transition Support (Other)
Control/ Usual Care
Standard of care in the control group will involve the utilization of existing tools within clinical programs which may include preparation for transitions, but there will be no systematic follow-up by a paediatric provider beyond age 18. Care will be transferred to adult providers (primary care and specialists) via a transition guide that will be offered to participants and their referring providers. This is the current model of care for virtually all CMC in Ontario.
结局指标
主要结局
Transfer Completion
时间窗: 6 to 30 months
Successful transfer of primary and subspecialty care to continuous primary care and a prioritized subspecialty in adult care will be measured using a relational continuity of care measure - the Bice Boxerman Index (modified for the study population).
次要结局
- Transfer Completion(Baseline to 24 months)
- Early Identification and Transition Readiness- Satisfaction with Transitional Healthcare(Baseline, 12 months and 24 months)
- Information Sharing and Support, Transition Plan and Coordinated Transition(Baseline, 12 months and 24 months)
- Introduction to Adult Services(24 months)
- Use of Services(Baseline to 24 months)
- Health-Related Quality of Life- Family Distress(Baseline, 12 months and 24 months)
- Experiences in The Process(12 to 24 months)
- Early Identification and Transition Readiness- Self-Care(Baseline)
- Health-Related Quality of Life-Caregiver Fatigue(Baseline, 12 months and 24 months)
- Health-Related Quality of Life(Baseline, 12 months and 24 months)
- Use of Services- Incremental Cost-Utility Ratio (ICUR)(Baseline to 24 months)
- Transfer Completion(6 to 30 months)
- Early Identification and Transition Readiness- Self-Care(Baseline, 12 months and 24 months)
研究者
Eyal Cohen
Program Head and Senior Scientist, Child Health Evaluative Sciences
The Hospital for Sick Children